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Cognitive Bias Modification (CBM) and Internet Cognitive Behavioural Therapy (iCBT) for Depression- A Randomised Controlled Trial

This study has been completed.
Sponsor:
Collaborator:
The University of New South Wales
Information provided by (Responsible Party):
Alishia Williams, St Vincent's Hospital
ClinicalTrials.gov Identifier:
NCT01488058
First received: December 5, 2011
Last updated: September 18, 2012
Last verified: September 2012
  Purpose

Cognitive accounts of depression and anxiety emphasize the importance of cognitive biases in the maintenance of disorders. One specific bias is the interpretation of ambiguous information. A negative interpretation bias is defined as a systematic tendency to interpret potentially ambiguous information in a negative rather than benign way and this bias has been associated with symptoms of depression. Research has led to the recent development of computerized cognitive bias modification (CBM) techniques to augment such biases and it has been suggested that CBM techniques may be useful as an adjunct to current treatments to enhance maintenance of treatment gains and minimize relapse rates. The fact that CBM procedures lend themselves to being delivered remotely, are cost-effective, and can be self-paced in ways that suit the patient make them an ideal candidate for inclusion in the Internet-based cognitive behavioural therapy (iCBT) programs currently offered through St. Vincent's Hospital and the University of New South Wales. Therefore, the primary aim of the current trial is to evaluate the acceptability and effectiveness of adding CBM procedures to the existing iCBT modules offered through St. Vincent's Hospital and the University of New South Wales. It is expected that iCBT + CBM will result in superior treatment outcomes as indexed by a standardized clinical battery.


Condition Intervention
Depression
Other: OxIGen + iCBT
Other: Waitlist Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial Comparing Internet Based Cognitive Behavioural Therapy for Major Depressive Disorder Plus a Cognitive Bias Modification Intervention (OxIGen) vs. Internet Based Cognitive Behavioural Therapy for Major Depressive Disorder vs. a Waitlist Control on Symptoms of Depression and Negative Interpretation Bias.

Resource links provided by NLM:


Further study details as provided by St Vincent's Hospital, Sydney:

Primary Outcome Measures:
  • Change in score on the Beck Depression Inventory - second edition (BDI-II). [ Time Frame: Administered at baseline, post-intervention (1 week), and post treatment (iCBT; 11 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change on the Scrambled Sentences Task (SST)- electronic version. [ Time Frame: Administered at baseline, post-intervention (1 week). ] [ Designated as safety issue: No ]
  • Change on Prospective Imagery Test (PIT). [ Time Frame: Administered at baseline, post-intervention (1 week). ] [ Designated as safety issue: No ]
  • Change on the Kessler-10 (K10). [ Time Frame: Administered at baseline, before each iCBT lesson, and post-treatment (week 11). ] [ Designated as safety issue: No ]
  • Change on WHO Disability Assessment Scale (WHO-DAS). [ Time Frame: Administered baseline and post-treatment (iCBT; 11 weeks). ] [ Designated as safety issue: No ]
  • Change on the Repetitive Thinking Questionnaire (RTQ). [ Time Frame: Administered at baseline, post intervention (week 1), and post-treatment (iCBT; 11 weeks). ] [ Designated as safety issue: No ]
  • Change on the State Trait Anxiety Inventory (STAI). [ Time Frame: Administered at baseline, post intervention (week 1), and post-treatment (iCBT; 11 weeks). ] [ Designated as safety issue: No ]
  • Change on the Ambiguous Sentence Task (AST). [ Time Frame: Administered at baseline and post-intervention (week 1). ] [ Designated as safety issue: No ]
  • Change in score on the Patient Health Questionnaire-9 (PHQ-9). [ Time Frame: Administered at baseline, post intervention (week 1), and post treatment (week 11). ] [ Designated as safety issue: No ]

Enrollment: 69
Study Start Date: December 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group 2
Waitlist control
Other: Waitlist Control
Waitlist will receive iCBT at week 11
Other Name: Waitlist Control
Experimental: Group 1
CBM intervention (OxIGen) plus Internet based Cognitive Behavioural Therapy for depression
Other: OxIGen + iCBT
OxIGen is an Internet-based intervention taking place over 1 week followed by iCBT, an Internet-based treatment for depression taking place over 10 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meet Diagnostic and Statistical Manual of the American Psychiatric Association - 4th edition (DSM-IV) criteria for Major Depressive Disorder,
  • Internet access + printer access,
  • Australian resident,
  • Fluent in written and spoken English.

Exclusion Criteria:

  • Current substance abuse/dependence,
  • Psychotic mental illness (Bipolar or Schizophrenia),
  • Current or planned psychological treatment during study duration,
  • Change in medication during last 1 month or intended change during study duration,
  • Use of Benzodiazepines,
  • Suicidal.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01488058

Locations
Australia, New South Wales
St. Vincent's Hospital
Darlinghurst, New South Wales, Australia, 2010
Sponsors and Collaborators
Alishia Williams
The University of New South Wales
Investigators
Principal Investigator: Gavin Andrews, AO, MD St. Vincent's Hospital, The University of New South Wales
Principal Investigator: Alishia Williams, PhD; MPsychol(Clinical) St. Vincent's Hospital, The University of New South Wales
  More Information

No publications provided

Responsible Party: Alishia Williams, Principal Investigator, St Vincent's Hospital
ClinicalTrials.gov Identifier: NCT01488058     History of Changes
Other Study ID Numbers: 11/055, ACTRN12611001221943
Study First Received: December 5, 2011
Last Updated: September 18, 2012
Health Authority: Australia: Human Research Ethics Committee

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on November 25, 2014